FDA approval of Makena and all generic forms of 17-alpha hydroxyprogesterone caproate injection (17-OHP), was withdrawn on April 6, 2023

Please refer to the American College of Obstetricians and Gynecologists (ACOG) guidance regarding the use of progesterone for the prevention of preterm birth that can be found in ACOG Practice Bulletin No. 234, “Prediction and Prevention of Spontaneous Preterm Birth” (linked here) for additional information.

Information current as of: